Supporting the clinical lab in chemistry, microbiology, and hematology

Peter Costas Vice President, Sales and Marketing, Advanced Instruments

Professional:
Joined Advanced Instruments in January 2004. Previously, served as the Director of Sales at Astra Tech (2000-2003) Vice President of Sales and Marketing at Navix Diagnostix (1995-2000) Director of Sales and Marketing at Elkay Products (1987-1995) and Project Leader at Arthur D. Little (1980-1987).

Education:
BS in Chemical Engineering from Northeastern University, Boston, Massachusetts.

Personal:
Spending time with my wife and family. Fitness is important to us, so we work out regularly. We enjoy the beach and skiing whenever time permits.

How would you characterize Advanced Instruments’ primary areas of expertise? What major categories of solutions does the company provide for the clinical lab? Advanced Instruments (AI) is a manufacturer of bench-top laboratory instrumentation. We support the clinical lab in three major areas: chemistry (osmolality testing, neonatal bilirubin), microbiology (anaerobic culturing), and now hematology (cell enumeration in cerebrospinal fluid).

We are an authority on the application Freezing Point Depression technology for measuring the osmolality of solutions. When a solute is dissolved in a solvent, the freezing point of the resulting solution is lower than that of the solvent alone. As more solute is added, the freezing point decreases further. A good example is putting salt on a frozen walkway to melt the ice. By precisely measuring the freezing point of a solution (to 0.001°C), the osmolality, or concentration, can be determined.

Concentration gradients of dissolved solutes create osmotic pressure across semipermeable membranes. Because the flow of water into and out of mammalian cells is influenced by the osmotic pressure, your body controls the osmolality of blood very tightly. Clinically, osmolality testing is most often used to monitor blood and urine.

AI also manufactures the BR2 Bilirubin Stat-Analyzer, a dedicated, bench-top analyzer measuring total and direct bilirubin in neonatal blood. Hyperbilirubinemia is one of most common problems encountered in term newborns. Excessive bilirubin damages developing brain cells in infants and may cause learning and developmental disabilities, hearing loss, or eye movement problems. It is important that bilirubin levels in newborns be monitored and actions taken if the levels get too high.

Our Anoxomat System is designed to create ideal anaerobic conditions (that is, no oxygen) in sealed jars for the cultivation of bacteria. Anaerobic bacteria are common causes of infections, but will be completely missed in clinical diagnosis unless special precautions are taken during culturing. The system can also create microaerophilic (low levels of oxygen), and capnophilic (high level of carbon dioxide) conditions through the application of a gas evacuation and replacement method.

And, this past year AI introduced the GloCyte Automated Cell Counter for Cerebrospinal Fluid (CSF). We use a novel combination of fluorescence, microscopy with digital image analysis principles, highly specific reagents, and an intelligent counting algorithm to provide accurate and precise cell counts.

You unveiled the OsmoPRO at last summer’s AACC conference. What is distinctive about this product? OsmoPRO is a 20-position multi-sample osmometer designed specifically to improve efficiency and reduce sample turnaround time. Ideal for sample-limited applications, OsmoPRO uses a 20 µL sample. Samples can be analyzed one at a time, or batch-processed depending on the workflow demands.

Time-saving features, like the ability to run tests unattended, automated processing of up to 20 samples, and the intuitive touchscreen, were designed to enable lab staff to manage time effectively. The OsmoPRO was designed with a set of usability, connectivity, and software control features. The integrated 2-D barcode scanner provides positive sample identification to reduce transcription errors. Data management and transfer can be handled by either the on-board printer or by easily exporting the data using the Ethernet connection, and multiple USB ports. The system stores the last 1,000 test results, provides integrated search functionality for easy retrieval of test results, calculates statistics for selected test results, and includes statistical monitoring of daily QC in addition to custom range and action limits for out of range QC results.

Your GloCyte Automated Cell Counter System received FDA clearance in July, and it was also launched at AACC. What is distinctive about the System, and how is it being received? We are very excited about this new product. The GloCyte System is intended to provide a quantitative determination of red blood cells (RBCs) and total nucleated cells (TNCs) in CSF collected from adult and pediatric patients. CSF is collected when physicians rely on cell counts to assist in the diagnosis of infections, inflammatory processes, hemorrhage, leukemia, and malignancies that may involve the central nervous system. Currently, low cell counts can present a challenge to standard methods.

GloCyte delivers highly accurate and precise TNC and RBC results using 30 µL per assay, with a total test time in under five minutes of one or two specimens. GloCyte can handle all of the CSF specimens that enter the laboratory, providing cell counts at clinically relevant low levels, and reducing valuable time spent counting more difficult specimens. GloCyte uses disposable test cartridges, ensuring no sample carryover and easy disposal, and it includes built-in quality control using Levey-Jennings charts and an audit table.

The market’s acceptance has been great. Specifically users have noted “an improvement in test turnaround time and workflow.”

I understand you have been with AI since 2004—a pretty long time, by today’s industry standards. How does that kind of institutional longevity help you be an effective leader? Over time, you can measure the value of treating the customer right. Do whatever it takes to solve your customers’ problems and you create repeat business. You actually create your brand. Our brand is quality and service. The team here knows that management will support them when they act with the customers’ best interests in mind — even if it costs us a little more. Through our service organization in the U.S. and over 120 distributors around the globe, we provide 24/7 support.

How has the market for laboratory equipment changed since 2004? Lab managers and supervisors are being asked to do more every day with less money and staff. High turnover rates of technicians/technologists make proper training difficult. Increasing pressure on clinical laboratories is driving the need for automation more than ever. Instruments providing better accuracy, faster turnaround time, and reduced variability among staff provide great value to the laboratories.

Please tell more about AI’s family of osmometers. How do they meet the needs of labs of different types, sizes, or degrees of automation? The osmometers are designated by sample size, operating range, number of samples, and degree of automation. For laboratories doing a limited number of samples per day, we offer Models 210 and 3320. These instruments are single sample units, require only 20 µL of sample, and have an operating range from 0-2000 mOsm/kg H2O. If the laboratory needs a wider operating range, we offer the Model 3250. It has a range from 0-4000 mOsm/kg H2O, requires a 250 µL sample, and is also a single sample unit.

If the laboratory processes a higher volume of samples and desires some degree of automation, we offer the OsmoPRO and our fully-automated A2O osmometer. The A2O is highly automated, with direct primary tube sampling—the 20 position sample tube carousel accommodates most tube sizes and shapes, positive sample identification through an integrated bar code scanner, a touch screen user interface, and bi-directional data
communications.

What is the technology behind AI’s BR2 Bilirubin Stat-Analyzer, and what are its clinical applications? The Advanced Model BR2 Bilirubin Stat-Analyzer is a dual-wavelength, narrow band-pass photometer that measures total bilirubin (TBR) and azobilirubin (DBR) absorbance. It determines Total Bilirubin by spectrophotometric analysis and Direct Bilirubin using a modified version of the Malloy-Evelyn method. The maximum light absorption of bilirubin occurs at a wavelength of 454 nm. Oxyhemoglobin (HbO2) has nearly equal absorbance at 454 and 540 nm. In the BR2, the absorbance at 540 nm (HbO2) is subtracted from the absorbance at 454 nm (TBR + HbO2). The remainder corresponds to TBR concentration corrected for oxyhemoglobin up to 600 mg/dL.

Direct bilirubin is measured as the change in absorbance at 540 nm due to the formation of azobilirubin, using a two-minute, timed-endpoint modification to the Malloy and Evelyn method. After TBR has been measured on a sample, that same sample is acidified, establishing an absorbance baseline. Next, diazotized sulfanilic acid is added. Under these conditions, the conjugated (Direct) bilirubin fraction will react to form azobilirubin, which has maximum light absorption at 540 nm.

AI started up in 1955. What were its leading products in the early years, and how, broadly, have they changed over time? Not surprisingly, our first products commercialized freezing point depression technology, but the application was measuring added water in milk. Raw milk has a freezing point of approximately 0.5°C below zero. If milk is diluted with water (inadvertently or by design), the freezing point rises in proportion to the amount of water added. While cryoscopy was well known in research and academia, the company founder, Bud Wiggin, believed the technology would find broad application in the clinical laboratory. Bud actually coined the term “osmometer” from the concept of osmotic pressure.

AI was founded at a time when electronic automation was just beginning to be applied to laboratory methods. The first osmometers were huge by today’s standards, weighing close to 100 pounds, and were very labor-intensive. The laboratorian manually adjusted the temperature up and down, and determined the freezing point by watching ice crystals form and melt in the sample thorough a magnifying lens and a response on a galvanometer. The test took about 20 minutes. AI helped establish the method with nephrologists, making it a staple of lab medicine.

Other early products included flame photometers, sweat testing for cystic fibrosis diagnosis, diagnostics for pulmonary function, and perfusion apparatus for cardiac bypass surgery.